Spots Global Cancer Trial Database for A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay

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Trial Identification

Brief Title: A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay

Official Title: Prospective Observational Study to Evaluate the Impact of the Determination of the Intrinsic Subtypes of Breast Cancer by PAM50 NanoString Technology in the Use of Adjuvant Chemotherapy in Women With Breast Cancer, HR+ and Node -.

Study ID: NCT01899079

Conditions

Breast Cancer

Interventions

Study Description

Brief Summary: The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.

Detailed Description: Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the Prosigna test.